# K090168: Azur Detactable 18, Models 45-480305, 45-480310, 45-480405, 44-480415

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Mar 12, 2009 after 48 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K951256 (1995). 42 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050954: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes), MicroVention, Inc. (2005) Summary page 1.

## Most influential descendants
- K093002: Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models 45-450405, 45-450410, 45-450610 (2009), 12 descendants of its own
- K123803: Reverse Medical Micro Vascular Plug (MVP) System (2013), 10 descendants of its own
- K133282: Reverse Medical Micro Vascular Plug (MVP) System (2013), 6 descendants of its own
- K141313: Reverse Medical Micro Vascular Plug System (2014), 5 descendants of its own
- K150108: Reverse Medical Micro Vascular Plug System (2015), 4 descendants of its own

## Indications for use
The Azur Detachable Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula. The coils are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct bloodflow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature.

Source page: https://510kreport.com/device/K090168
Methodology: https://510kreport.com/methodology